E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with mild to moderate atopic eczema |
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E.1.1.1 | Medical condition in easily understood language |
Subjects with neurodermatitis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003641 |
E.1.2 | Term | Atopic eczema |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective is to evaluate efficacy of Tarenflurbil Spray 4 % on lesional skin by clinical assessment of skin condition in subjects with mild to moderate atopic eczema.
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to assess the effect of Tarenflurbil Spray 4 % on barrier impairment by measurement of transepidermal water loss (TEWL) in subjects with mild to moderate atopic eczema. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• male or female subjects, 18 years or older;
• manifest atopic dermatitis diagnosed according to Hanifin and Rajka (3);
• two comparable lesional areas of 30 - 40 cm2 with a distance of at least 5 cm (difference in modified local SCORAD not greater than 2), clinical condition of atopic eczema mild to moderate; clinical condition of atopic eczema mild to moderate defined by a modified local SCORAD of at least 4 with
erythema ≥ 1
lichenification ≥ 1
dryness ≥ 1
• TEWL in the lesional areas at least 12 g/m²h, TEWL value differences ≤ 30 % are allowed between both lesional areas (related to the higher TEWL value);
• the physical examination of the skin must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial;
female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner;
• written informed consent obtained |
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E.4 | Principal exclusion criteria |
• acne, suntan, eczema other than atopic eczema, hyper- or hypopigmentation or tattoos in the treatment areas;
• dark-skinned persons whose skin color prevents ready assessment of skin reactions;
• evidence of drug or alcohol abuse;
• pregnancy or nursing;
• UV-therapy within 6 weeks before first treatment;
• symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before and during the trial;
• participation in the treatment phase of another clinical trial within the last four weeks prior to the first administration of investigational drug in this clinical trial;
• known allergic reactions to components of the investigational product/s;
• treatment with systemic or locally acting medications which might counter or influence the trial aim within four weeks before the baseline visit and during the trial, e.g. antihistamines or glucocorticosteroids (exception: asthma may be found in patients with atopic dermatitis, therefore inhalation with corticosteroids in patients with asthma accompanying atopic dermatitis will be allowed);
• in the opinion of the investigator or physician performing the initial examination the subject should not participate in the clinical trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent;
• close affiliation with the investigator (e.g. a close relative) or persons working at the study sites or subject is an employee of sponsor;
• subject is institutionalized because of legal or regulatory order |
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of active IMP vs. vehicle with respect to the change from baseline in modified local SCORAD on day 29 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Comparison of active IMP vs vehicle with respect to the change from baseline in modified local SCORAD on days 8 and 15
Modified local SCORAD on days 1, 8, 15, and 29
Change from baseline in TEWL on days 8, 15, and 29
TEWL on days 1, 8, 15, and 29
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
intra-individual comparison |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |